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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
July- August 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
This study was conducted according to GLP and sufficient data is available for interpretation of results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Guinea Pig Maximization Test
Deviations:
not specified
Remarks:
Not specified in report
Principles of method if other than guideline:
The study was conducted using procedures based on the method described by Bertil Magnusson and Albert M. Kligman in "The Identification of Contact Allergens by Animal assay. The Guinea Pig Maximization Test, "Journal of Investigative Dermatology, 57: 268-and in Allergic Contact Dermatitis in the Guinea Pig, Identification of Contact Allergens, Thomas, Springfield, IL, 1970.
GLP compliance:
yes
Remarks:
US EPA GLP Stds, 40 CFR Part 792
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA study does not need to be conducted because adequate reliable data is available from this alternative study providing data on the potential for skin sensitisation.

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethane-1,2-diol
EC Number:
203-473-3
EC Name:
Ethane-1,2-diol
Cas Number:
107-21-1
Molecular formula:
C2H6O2
IUPAC Name:
1,2-ethanediol
Test material form:
other: liquid
Details on test material:
Test Material: Ethylene Glycol
Description: Clear colorless liquid
Date of Receipt: June 29, 1989
Storage: Room temperature
Source: Union Carbide Corporation

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Stock: Hartley Albino
Supplier: Hazleton-Dutchland Laboratory Animals, Denver, Pennsylvania
Age: 3-4 weeks at receipt, 5-6 weeks old at study initiation
Pretest Weight Range: Males: 302 to 350 grams & Females: 305 to 346 grams
Equilibration Period: 15 days
Housing: Individually in suspended stainless steel cages
Animal Identification: Each animal was identified with an ear tag, bearing a unique animal number, prior to testing.
Light Cycle: 12 hours light, 12 hours dark (control led by an automatic timer).
Temperature: Monitored and recorded twice daily.
Humidity : Monitored and recorded daily
Food : Agway Purina Guinea Pig Diet, & Jibitu.
Water: Automatic watering system, ad libitum, Municipal water supply

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Remarks:
distilled
Concentration / amount:
1a . Range-finding Topical: 10, 25, 50% v/v in water, and 100%
1b . Range-finding Intradermal: 5% v/v in water
2a: Sensitization Study Induction: 100%
2a: Sensitization Study Challenge: 100%
3a. Irritation Controls Induction: water
3b. Irritation Controls Challenge: 100%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
distilled
Concentration / amount:
1a . Range-finding Topical: 10, 25, 50% v/v in water, and 100%
1b . Range-finding Intradermal: 5% v/v in water
2a: Sensitization Study Induction: 100%
2a: Sensitization Study Challenge: 100%
3a. Irritation Controls Induction: water
3b. Irritation Controls Challenge: 100%
No. of animals per dose:
1. Range-finding: 8 (4 males, 4 females): 6 (3 males, 3 females) for topical; 2 (1 male, 1 female) for Intradermal.
2. Sensitization Study: 20 (10 males, 10 females)
3. Irritation Controls: Challenge: 10 (5 males, 5 females)
Details on study design:
RANGE FINDING TESTS:
A. Intradermal Injection:
Two animals were administered intradermal injections (2 sites per animal) of a 5.0% v/v test material in water. Injections of 0.1 ml per site were made using a 1.0 cc syringe. Observations were made at 24 and 48 hours after injection. 5.0% concentration produced no necrosis (no extensive necrosis or ulceration) .
B. Topical:
6 aminals (3 males, 3 females) were used to determine the highest concentration which produced mild irritation (for induction) and the highest concentration which did not produce irritation (for challenge). Each animal was dosed with the four different concentrations (10, 25 and 50% v/v in distilled water and 100%), one concentration/site. After 24 hours, patches were removed and observations for signs of dermal irritation (erythema, edema and schar formation) were made approximately 24, and 48 hours after patch removal. Based on results, the undiluted material was found to be non-irritating and 100% concentration was used for both induction and challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2: Intradermal Injection at Day 0 and Topical at Day 7
- Exposure period: 48 hours
- Test groups: 20 animals
- Site: shoulder area pre-treated with 10% SLS
- Concentrations: undiluted material

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: Day 21
- Exposure period: 24 hrs
- Test groups: 20 animals
- Control group: 10 animals
- Site: flank
- Concentrations: undiluted material
- Evaluation (hr after challenge): 24 and 48 hrs
Challenge controls:
yes, 5 males and 5 females
Positive control substance(s):
not specified

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under conditions of this study, Ethylene Glycol exhibited no potential to produce dermal sensitization in the guinea pig.
Executive summary:

This study was conducted to evaluate the allergic contact sensitization potential of Ethylene Glycol in guinea pigs according to procedures described by Magnusson and Kligman. Animals challenged with Ethylene Glycol exhibited no dermal response at challenge to a non-irritating (100%) concentration, as confirmed by a lack of dermal response in irritation control animals and no dermal reactions recorded for test animals. Under conditions of this study, Ethylene Glycol exhibited no potential to produce dermal sensitization in the guinea pig.